# FDA recall Z-2144-2020

> **Biomet, Inc.** · Class II · device recall initiated 2020-04-17.

## Product

Extremities  Item Number:  1)113954		Hybrid Glenoid Glenoid Base, 4 MM  2) XL-115366	Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard  3) XL-115364	Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard   Product Usage:  is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

## Reason for recall

Potential presence of elevated endotoxin levels that exceed the specification limit

## Distribution

Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY,                        HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE,                             SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

## Key facts

- **Recall number:** Z-2144-2020
- **Recalling firm:** Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-17
- **Report date:** 2020-06-03
- **Termination date:** 2021-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2144-2020

## Citation

> AI Analytics. FDA recall Z-2144-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-2144-2020. Source: US FDA. Licensed CC0.

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